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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal EG6-2783580-4/1/1


Manufacturer FEI3002561751
Manufacturer NameSisley  
Manufacturer Address line 116 Avenue George V  
Manufacturer Address line 2  
Manufacturer's CityParis  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53YC99  
FDA Product DescriptionOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.  
Refusal Date15-Apr-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx EG6-2783580-4/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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